Bone fixation tensioning tool and method

ABSTRACT

A tensioning tool and method for tensioning a conformable ligature of a bone fixing system are disclosed. The ends of a conformable ligature can be passed around bones, bone grafts, tendons, plates, rods, fasteners, or other anatomical or implanted structures, and the like to form a loop. Another portion of the conformable ligature can be coupled to a tensioning tool. The tensioning tool can include a first portion and a second portion in threaded engagement with each other. Rotation of one portion relative to the other can cause tensioning of the conformable ligature through translation of a tensioning member.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/369,824, filed on Feb. 9, 2012, which is a continuation of U.S.patent application Ser. No. 11/877,160, filed on Oct. 23, 2007, now U.S.Pat. No. 8,128,635, issued on Mar. 6, 2012, the entire disclosures ofwhich are incorporated herein by reference.

TECHNICAL FIELD OF THE DISCLOSURE

This disclosure relates generally to systems and method for fixing bone.In particular, embodiments of the disclosure may be helpful for holdingbones, rods, or other structures in a desired configuration or inparticular relative position. Even more particularly, the disclosurerelates to instruments and methods for installing bone fixing systems.

BACKGROUND OF THE DISCLOSURE

The spine is formed of superposed vertebrae, normally aligned along avertebral axis, from the lumbar vertebrae to the cervical vertebrae,each having a posterior wall from which projects a spinous process andtwo lateral edges from the walls of which there project ribs and/ortransverse processes. If the spine of a person has abnormal curvature,the vertebrae are typically inclined relative to one another andrelative to said vertebral axis. The lateral edges of the vertebrae onone side are therefore closer together and form a concave shape whilethe lateral edges on the other side are farther apart and form a convexshape.

In order to straighten the vertebral column as a remedy for thissituation, the lateral edges of the vertebrae on the concave side can bemoved away from one another and supported at distances from one anothersubstantially equivalent to the distances between the lateral edges onthe other side. Devices known in the art to hold the vertebrae relativeto one another include screws that are inserted into the vertebrae orhooks that are inserted along the internal wall of the spinal canal androds adapted to connect the screws or hooks.

When using a hook and rod system, pairs of hooks are generally insertedinto each vertebra, one on each side, near the pedicle. The hookstypically have heads that project from the posterior wall of thevertebra, one on each side of the spinous process. The heads can betulip-shaped and adapted to receive a rod that is immobilized by a nutscrewed onto the head and contacting the rod. The heads of the hookssituated on either side of the spinous process can then be connectedtogether and fixed in position by two rods approximately parallel to oneanother and to the axis of the spine.

However, using such hooks can be difficult because their use increasesthe risk that the physician (or other operative) might contact andpotentially damage the spinal cord that extends along the center of thespinal canal (which can result in paralysis of the patient).

Using a screw and rod system reduces this risk, but has other drawbacks.The screws typically have tulip-shaped heads and are inserted in pairsinto the pedicles on each side of the spinous process on the posteriorwall of the vertebrae. The screws therefore constitute fixing points onthe vertebrae for holding the vertebrae in a fixed position relative toone another. However, the screws are inserted into the pedicles of thevertebrae, which in some cases are small or have deteriorated and can bedamaged or do not provide sufficient purchase to permanently hold thescrew.

SUMMARY OF THE DISCLOSURE

According to various embodiments described herein, a surgical procedurecan be performed using a tensioning tool that provides continuouscontrol over tensioning the ligature. A user can form a loop about oneor more structures in a patient's body with a conformable ligature and aligature capturing implant. The ligature capturing implant can be aligature capturing implant that include rods, compression members or canbe another type of ligature capturing implant. The structures caninclude, for example, a bone, a bone fastener, a tendon, a bone graft, aplate, a rod or other structure in the body. The user can attach aportion of the conformable ligature to a tensioning member of atensioning tool that provides a continuous range of control. Thetensioning tool can comprise a first portion in threaded engagement witha second portion. For example, the tensioning tool can comprise a driveshaft that engages with a carriage, a column that engages with athreaded shaft, a threaded shaft that engages with another shaft orother threaded portions that engage with each other to translaterotational motion of the portions relative to each other into linearmotion of the tensioning member. The user can rotate the first portionrelative to the second portion to move the tensioning member to tensionthe loop. For example, a user can rotate a drive shaft to move acarriage carrying the tensioning member. In some embodiments, the usercan disengage the carriage from the drive shaft and slide the carriagealong the drive shaft to a selected position. As another example, theuser can rotate one portion of the tool to move a shaft that is coupledto the tensioning member. The first portion can also be rotated relativeto the second portion in an opposite direction to release tension fromthe loop.

According to one embodiment, a spinal reduction can be performed usingtensioning tools. A method of progressive spinal reduction can compriseforming multiple loops about structures in a patient's body withmultiple conformable ligatures and ligature capturing implants andpartially tensioning each conformable ligature in turn with acorresponding tensioning tool until each conformable ligature is at adesired tension to perform spinal reduction procedure. Tensioning eachconformable ligature may comprise attaching a portion of thatconformable ligature to a tensioning member of the correspondingtensioning tool, the corresponding tensioning tool comprising a firstportion in threaded engagement with a second portion and rotating thefirst portion relative to the second portion to move the tensioningmember away from a corresponding ligature capturing implant to tensionthat conformable ligature about at least a portion of a vertebra. Thefirst portion is rotated relative to the second portion about an axisthat is substantially parallel to a primary direction of movement of thetensioning member.

Another embodiment of a method comprises providing a tensioning toolcomprising, a tool body defining a slot, a threaded drive shaft runningthrough at least a portion of the tool body, a tensioning member and acarriage coupled to the tensioning member. The carriage defines a driveshaft passage having at least one thread engaging portion to engagethreads on the drive shaft. The drive shaft passes through the driveshaft passage. The method further comprises forming a loop about one ormore structures in a patient's body with a conformable ligature and aligature capturing implant and coupling a portion of the conformableligature to the tensioning member. The method can further includerotating the drive shaft to move the carriage away from the ligaturecapturing implant to tension the conformable ligature. Embodiments canalso include rotating the drive shaft the opposite direction to releasetension from the loop. The structures about which the loop is formed caninclude, for example, a bone, a bone fastener, a tendon, a bone graft, aplate, a rod or other structure in the body.

According to one embodiment, the drive shaft passage includes one ormore additional unthreaded portions. The method can further compriserotating the carriage to disengage the at least one thread engagingportion from the threaded drive shaft and sliding the carriage along thedrive shaft to a desired position.

Another embodiment of a method for holding a bone in a position, themethod comprises passing a conformable ligature around one or morestructures in a body, passing first and second ends of the conformableligature through a loop passage in a ligature capturing implant to forma loop, adjusting the ligature capturing implant to increase toresistance on the movement of the conformable ligature to a selectedamount that allows the conformable ligature to move through the ligaturecapturing implant when a force is applied to the conformable ligature,attaching a portion of the conformable ligature to a tensioning memberof a tensioning tool, rotating a threaded drive shaft of the tensioningtool to move the tensioning member to apply tension to the conformableligature and adjusting the ligature tensioning implant to prevent theloop from loosening. According to one embodiment, rotating a threadeddrive shaft of the tensioning tool to move the tensioning membercomprises rotating the threaded drive shaft to move a carriage coupledto the tensioning member. The carriage can define a drive shaft passagehaving at least one thread engaging portion to engage threads on thedrive shaft and wherein the drive shaft passes through the drive shaftpassage. The method can further comprise positioning the tensioning toolso that a connecting portion of the tensioning tool abuts the ligaturecapturing implant. According to one embodiment the drive shaft can berotated in an opposite direction to release tension from the conformableligature.

According to one embodiment a drive shaft passage can include one ormore additional unthreaded portions. The method can further includerotating the carriage to disengage the at least one thread engagingportion from the threaded drive shaft and sliding the carriage along thedrive shaft to a desired position.

Another embodiment comprises a tensioning tool providing continuouscontrol of conformable ligature tension, the tensioning tool comprisinga tool body defining a slot, a connection portion shaped to at leastabut a ligature capturing implant, a threaded drive shaft runningthrough at least a portion of the tool body, a tensioning member and acarriage coupled to the tensioning member, the carriage defining a driveshaft passage having at least one thread engaging portion to engagethreads on the drive shaft and wherein the drive shaft passes throughthe drive shaft passage, wherein rotation of the drive shaft causes thecarriage to move towards or away from the connection portion. Accordingto one embodiment, the carriage is configured to be rotated from a firstposition in which the at least one thread engaging portion is engagedwith threads on the drive shaft to a second, slidable position, in whichthe at least one thread engaging portions is not engaged with thethreads of the drive shaft.

The tensioning tool can further comprise a drive shaft seat in which afirst end of the drive shaft is seated, a spring that compresses betweenthe drive shaft seat of and the tool body, and a removable handleconnected to a second end of the drive shaft distal from the first end.

Embodiments of the disclosed systems and methods can provide theadvantage of providing progressive and continuous tensioning of aligature used in bone fixing procedures.

Embodiments of the disclosed systems and methods can provide theadvantage of allowing tension of the ligature to be progressivelyreduced in an easily controlled manner.

Embodiments of the disclosed systems and methods provide anotheradvantage by allowing a tensioning tool used to tension one ligature tobe left in place while the other ligatures are tightened.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is a fragmentary diagrammatic perspective view showing avertebral fixing system of the disclosure and a rod.

FIG. 2 is a diagrammatic view in vertical section of the subject matterof the disclosure mounted on a rod.

FIG. 3 is a diagrammatic perspective view in section of the subjectmatter of the disclosure.

FIG. 4 is a diagrammatic view in elevation of the subject matter of thedisclosure mounted on a vertebra.

FIG. 5 is a perspective view of a first embodiment of a vertebral fixingsystem.

FIGS. 6A, 6B, and 6C are vertical section views of the fixing systemshowing the use of said system as shown in FIG. 5.

FIG. 7 is a face view showing the FIG. 5 fixing system put into place ona vertebra.

FIG. 8 is a perspective view of a second embodiment of the fixingsystem, the ligature not being shown.

FIG. 9 is an exploded view of the connection device of FIG. 8.

FIG. 10 is a plan view of a portion of the FIG. 9 connection device.

FIG. 11 is a section view on line AA of FIG. 10.

FIG. 12 is a face view of the fixing system of the second embodiment.

FIGS. 13A and 13B are section views on line VII-VII of FIG. 12 showingtwo ways in which the flexible ligature can be put into place.

FIG. 14 depicts a cross-sectional end view of one embodiment of a bonefixing system.

FIG. 15 depicts an exploded perspective view of one embodiment of ablocking body.

FIG. 16 depicts a perspective view of one embodiment of a compressionmember.

FIG. 17 depicts a cross-sectional end view of one embodiment of a bonefixing system.

FIG. 18 depicts a side view of one embodiment of a bone fixing system.

FIG. 19 depicts an exploded view of one embodiment of a blocking body.

FIG. 20 depicts an exploded view of one embodiment of a bone fixingsystem.

FIG. 21 depicts a side view of one embodiment of a blocking body.

FIG. 22 depicts an exploded view of a portion of a blocking body.

FIG. 23 depicts a cross-sectional end view of one embodiment of a bonefixing system.

FIG. 24 depicts a side view of one embodiment of a blocking body.

FIG. 25 depicts an exploded view of one embodiment of a blocking body.

FIG. 26 depicts a perspective view of one embodiment of a blocking body.

FIG. 27 depicts a cross-sectional side view of one embodiment of a bonefixing system.

FIG. 28 depicts a perspective view of one embodiment of a bone fixingsystem.

FIG. 29 depicts a perspective view of one embodiment of a bone fixingsystem attached to a portion of bone.

FIG. 30 depicts a posterior view of one embodiment of a bone fixingsystem attached to a portion of a bone.

FIG. 31 depicts a sagittal view of one embodiment attached to a portionof a spine, illustrating a method for repairing a spine.

FIGS. 32-38 depict views of a bone fixing system implanted on a spine.

FIG. 39 depicts a side view of one embodiment of a tensioning tool for abone fixing system.

FIG. 40 is a diagrammatic representation of another embodiment oftensioning tool.

FIG. 41 is a cross sectional view of one embodiment of a tensioningtool.

FIGS. 42A-42B are diagrammatic representations of another embodiment ofa tensioning tool.

FIGS. 43A-43B are diagrammatic representations of a portion of atensioning tool.

FIG. 44 is a diagrammatic representation of yet another embodiment of atensioning tool.

DETAILED DESCRIPTION

The disclosure and the various features and advantageous details thereofare explained more fully with reference to the non-limiting embodimentsthat are illustrated in the accompanying drawings and detailed in thefollowing description. Descriptions of well known starting materials,processing techniques, components and equipment are omitted so as not tounnecessarily obscure the disclosure in detail. Skilled artisans shouldunderstand, however, that the detailed description and the specificexamples, while disclosing preferred embodiments of the disclosure, aregiven by way of illustration only and not by way of limitation. Varioussubstitutions, modifications, additions or rearrangements within thescope of the underlying inventive concept(s) will be apparent to thoseskilled in the art after reading this disclosure.

A bone fixing system may be installed in a patient to hold or fix onestructure in a selected relation with one or more other structures. Asused herein, the term structure may refer to bones, portions of bones,or bone implants, as well as rods, elongated members, plates, or otherimplanted man-made devices. Among other methods, a bone fixing system asdescribed herein may be installed using a minimally invasive surgery(MIS) procedure. In one embodiment, the bone fixing system and method ofuse may include instruments and bone fixing components for maintainingone or more structures in a selected alignment.

Components of bone fixing systems in accordance with the disclosure maybe made of materials including, but not limited to, titanium, titaniumalloys, stainless steel, ceramics, and/or polymers. Some components of abone fixing system may be autoclaved and/or chemically sterilized.Components that may not be autoclaved and/or chemically sterilized maybe made of sterile materials. Components made of sterile materials canbe used with other sterile components during assembly of a bone fixingsystem.

Embodiments of bone fixing systems disclosed herein are useful inrepairing broken bones, correcting curvatures of the spine and for othersurgical procedures that hold structures (e.g., bones) in a fixedrelative position. Embodiments of the bone fixing system and method ofuse disclosed herein can be particularly useful for minimally invasivesurgery (MIS) procedures, which can reduce trauma to soft tissue due tothe relatively small incision made in a patient. For example, a surgicalprocedure may be performed through a 2 cm to 4 cm incision formed in theskin of the patient. Dilators, a targeting needle, and/or a tissue wedgemay be used to provide access to structures without the need to form alarger incision with a scalpel through muscle and other tissue. Aminimally invasive surgery (MIS) procedure may reduce an amount ofpost-operative pain felt by a patient as compared to invasiveprocedures. A minimally invasive procedure may also reduce recovery timefor the patient as compared to invasive procedures. In some embodiments,the natural flexibility of skin and soft tissue may be used to limit thelength and/or depth of an incision or incisions needed during theprocedure. Minimally invasive procedures may provide limited directvisibility in vivo.

Bone fixing systems may be used to correct problems due to spinalinjury, deformity, or disease. For example, various embodiments of abone fixing system may be used from the C1 vertebra to the sacrum tocorrect spinal problems. For example, a bone fixing system may beimplanted posterior to the spine to maintain distraction betweenadjacent vertebral bodies in a lumbar portion of the spine. Variousembodiments of a bone fixing system may be used to correct orthopedicdeficiencies. Embodiments of the disclosure may be useful for holdingtendons, bones, or muscles during the healing process and may beimplanted using MIS procedures and thus it is in this context thatembodiments of the disclosure may be described. It will be appreciated,however, that embodiments of the systems and methods of the presentdisclosure may be applicable for stabilizing other areas of the body.

In general, a flexible ligature can be used to secure bones or otherstructures. The ligature comprises an elongate flexible member capableof conforming to the contour of the parts that it connects. The ligaturecan be passed through a ligature capturing implant to form a loop thatis looped about the structures to fixed relative to each. The ligaturecapturing implant can be any body through which the ligature passes toform a loop and that allows the loop to be tightened and left in apatient's body in a tightened state. According to one embodiment, forceis applied to the ligature to tension the loop. The instrument used totighten the ligature can include a first shaft, a second shaft drivablyengaged with the first shaft and a tensioning member. The tensioningmember can be coupled to the first shaft or the second shaft or can bedrivably engaged with one or both of the first shaft and the secondshaft. A portion of the ligature couples to the tensioning member suchthat movement of tensioning member can increase the tension in theligature. For example, a portion of the ligature can be formed into aloop that is looped around the tensioning member. Movement of thetensioning member can be driven by rotational movement of the firstshaft relative to the second shaft. Embodiments of an instrumenttensioning the ligature are discussed below in conjunction with FIGS.40-44.

By way of context, FIG. 1 shows one embodiment of a bone fixing system,specifically a vertebral fixing system 10 of the disclosure mounted on arod 18. The vertebral fixing system comprises a connecting part 12having two longitudinal members, of which a first longitudinal member 22extends between a first end 22 a and a second end 22 b and a secondlongitudinal member 20 extends between a first end 20 a and a second end20 b. The two longitudinal members 22 and 20 are pivoted together attheir first ends 20 a and 22 a for the purposes of mounting the system.The first end 22 a of the longitudinal member 22 has a notch 26 with twoopposite edges 28 and 30 and between which the first end 20 a of theother longitudinal member 20 may be inserted. A pivot pin 24 passesthrough the two first ends 20 a and 22 a and is free to rotate in atleast one of said ends 20 a and/or 22 a. The second end 22 b of thefirst longitudinal member 22 includes a bore 28 into which a screw 26may be inserted. The second end 20 b of the second longitudinal member20 comprises a thread 38 which is aligned with said bore 28 when the twolongitudinal members are disposed facing each other, with the resultthat the screw 26 may be screwed into said thread 38 in order to drivethe second ends 20 b and 22 b of the two longitudinal members 20 and 22towards each other. The consequences of screwing said screw 26 into thethread 38, thereby forming the adjustable locking means, are explainedin more detail hereinafter FIG. 1 also shows a first orifice 40 throughwhich a ligature may be stretched. The method of connecting saidligature to said connecting part is described with reference to FIG. 2.

FIG. 2 shows the connecting part 12 comprising of the first longitudinalmember 22 and the second longitudinal member 20, said longitudinalmembers 22 and 20 pivoting about the pin 24 that joins them. Theadjustable locking means comprising of said screws 26 passing throughthe bore 28 and screwed into the thread 38 to immobilize said connectingpart 12 relative to the rod 18 and fix in position a portion of aligature 14 shown in part in FIG. 2.

The ligature 14 consists of an elongate flexible member capable ofconforming to the contour of the parts that it must connect.

The ligature 14 has a first end 44 that is ligated around the pin 24 anda free second end 42 that is inserted into a passage 48 between the rod18 and the internal walls 50 and 52 of the longitudinal members 22 and20 and the external wall of the rod 18. As shown in FIG. 2, the secondlongitudinal end 20 a includes a second orifice 54 through which saidligature 14 passes. Moreover, as shown in FIG. 4, the ligature 14 may beformed into a loop 56 in which the transverse process is trapped. Insome embodiments, the ligature 14 may also trap the rib.

As shown in FIG. 3, which shows the second longitudinal member 20, themiddle part has a first portion through which said ligature 14 passesand a second portion 58 adapted to bear directly on the rod 18. In someembodiments, the passage 48, which is symmetrical inside the firstlongitudinal member 14, is produced by a groove formed in each of thetwo facing faces of the middle parts of the longitudinal members 22 and20.

In some embodiments, the first portion of the middle part forms an edgewith cylindrical symmetry and that the corresponding second portion ofthe middle part 58 of the first longitudinal member 22 forms asubstantially cylindrical space 60 into which said rod 18 is inserted.

FIG. 2 shows that the second portion 58 of the middle part comes intocontact with the rod 18 and is adapted to bear on top of it and thefirst portion presses the free second end of said ligature 14 againstthe rod 18. The adjustable locking means therefore drive thelongitudinal members 22 and 20 forcibly against the rod 18 andsimultaneously against the ligature 14, which is also forcibly pressedagainst the rod 18.

In some embodiments, as shown in FIG. 2, the passage 48 has a section S1in the vicinity of the orifice 54 greater than the section S2 in thevicinity of the first orifice 40, the section of said passage 48decreasing progressively in the direction from the second orifice 54 tothe first orifice 40. The ligature 14 is therefore progressivelycompressed around a portion of the rod 18 with a pressure that increasesin the direction from the second orifice 54 towards the first orifice40.

FIG. 4 shows a vertebral fixing system of the disclosure mounted on avertebra having a transverse process. This figure shows again the rod 18and the two longitudinal members 22 and 20 that grip it and press aportion of the ligature 14 against said rod 18.

In FIG. 4, the flexible ligature 14 consists of a flexible strip ofsubstantially constant width and thickness whose first end is ligated tothe pin 24, the ligature 14 surrounding the transverse process of thevertebra being inserted through the connecting part 12. The section ofthe flexible strip 14 is substantially rectangular so that, the pin 24and the rod 18 being substantially perpendicular to the transverseprocess, the ligature 14 has to be partly twisted in order to insert itinto the passage 48 and between the pin 24 and the point at which itcontacts the transverse process. The connecting part 12 is fixed inposition against the posterior wall of the vertebra despite thesepartially twisted portions, the ligature 14 being forcibly tensioned bystretching the free second end 14.

The ligature 14 is advantageously made from a flexible material such aspolyester that may be lightly crushed locally to immobilize it with aclamping effect.

One aspect of the disclosure relates to a spine straightening assemblycomprising a plurality of vertebral fixing systems conforming to thepresent disclosure and mounted on a plurality of successive vertebrae,on all the transverse processes of one lateral wall thereof, andconnected to a single rod that is disposed substantially parallel tosaid spine. The transverse processes of a portion of the spine cantherefore be connected together by a single longitudinal rod, to fixthem in position relative to each other, by means of the above vertebralfixing system.

In some embodiments, flexible ligature 14 may not be ligated around pin24 or otherwise fixed to connecting part 12. As shown in FIG. 5, in oneembodiment, a vertebral fixing system comprises a connecting part 12, aflexible ligature 14, and adjustable locking means 16. The flexibleligature 14 is of elongate shape and is capable of matching the outlineof the parts it is to connect together. In this figure, there can alsobe seen the rod 18 that is to be secured to the vertebra by means of thevertebral fixing system. In the first embodiment, the connecting part 12is constituted by two longitudinal elements given respective references22 and 20, each having a first end 22 a, 20 a and a second end 22 b, 20b.

In FIG. 6A, the longitudinal elements 22 and 20 are hinged to each otherat their second ends 22 b, 20 b about a pivot pin 24.

In the embodiment described, the locking means are constituted by ascrew 26 having a head 26 a that is engaged in a bore 28 formed in thefirst end 22 a of the longitudinal element 22. The first end 20 a of thelongitudinal element 20 is pierced by a tapped bore 38 for co-operatingwith the threaded shank 26 b of the screw 26. Each longitudinal element20, 22 has an outside face 20 c, 22 c and an inside face 20 d, 22 d. Thelongitudinal elements 20 and 22 are mounted in such a manner that theinside faces 20 d, 22 d of the longitudinal elements face each other.The inside faces 20 d, 22 d of the longitudinal elements 20 and 22 haverespective mutually-facing recesses 30 and 32, each of substantiallysemicylindrical shape. The recesses 30 and 32 define walls 34 and 36which are ruled surfaces having generator lines parallel to the pivotaxis 24. Finally, slots 54 and 40 cause the bottoms of the recesses 30and 32 to communicate with the outside faces 20 c and 22 c of thelongitudinal elements 20 and 22. As explained below, the recesses 30 and32 are for receiving the rod 18 together with a strand of the ligature14, the slots 54 and 40 serving to pass the ligature 14.

With reference to FIGS. 6A, 6B and 6C, there follows an explanation ofhow the fixing system is used.

In FIG. 6A, there can be seen the longitudinal elements 20 and 22 in thespaced-apart position, a position in which the locking means 16 are notactive, the threaded shank 26 b of the screw 26 not being engaged in thebore 38. The ligature 14 is engaged in the slots 54 and 40 of thelongitudinal elements against one portion of the inside wall 34, 36 ofthe recesses 30 and 32. The rod 18 is then introduced into the recess 30of the longitudinal element 20 so that the two strands 42 and 44 of theligature 14 are disposed between the inside wall of the recesses 30 and32 and the side face 18 a of the rod 18. These two surfaces define apassageway 48 for passing the ligature 14 and having portions 42 and 44of the ligature 14 placed therein.

As shown in FIG. 6B, the portions 42 and 44 of the ligature 14 define aportion of the ligature 14 that forms a loop that extends beyond theoutside face 20 c of the longitudinal element 20, and also two freeportions 42 and 44 that extend beyond the outside face 22 c of thelongitudinal element 22. When the longitudinal elements 20 and 22 arespaced apart as shown in FIG. 6B, the ligature 14 can slide freely alongthe passageway 48. Once the ligature 14 is placed around the transverseprocess or a rib or indeed a portion of the posterior arc of a vertebra,the surgeon engages the threaded shank 26 b of the screw 26 in thetapped bore 38, causing the longitudinal element 22 to comeprogressively closer to the longitudinal element 20. This approachsimultaneously reduces the section of the passageway 48 in which theportions 42 and 44 of the ligature 14 are engaged and simultaneouslyintroduces a certain coefficient of friction between the ligature andrespectively the rod 18 and the walls of the recesses 30 and 32.Nevertheless, it is still possible for the surgeon to extract tractionon the free ends 42 and 44 of the ligature 14 until sufficient tensionis obtained in the ligature around the vertebral process. Once thetension in the ligature is sufficient for providing appropriatefastening, the surgeon finishes off tightening the screw 26 in thetapped bore 38, thus locking the longitudinal elements 20 and 22together. Advantageously, the portions 42 and 44 of the ligature 14 arepinched between the rod 18 and the wall of the recesses 30 and 32.

In this locking position, the rod 18 is thus secured to the ligature 14via the connecting part 12.

Advantageously, because the surgeon exerts traction only on the freeends 42 and 44 of the ligature 14, there is no risk of jamming betweenthe ligature 14 and the bottom face of the transverse process or of therib, thus guaranteeing that effective fastening is provided with thetransverse process or the rib or indeed a portion of the posterior arcof a vertebra. FIG. 7 depicts a face view where reference AT identifiesthe transverse process.

In the above description, both of the portions 42 and 44 of the ligature14 are disposed in the recesses 30 and 32 on the same side of the rod18. In some embodiments, the portions 42 and 44 of the ligature 14 maybe placed on opposite sides of the rod 18. Under such circumstances, itshould be considered that the outside face 18 a of the rod 18 and theinside walls of the recesses 30 and 32 define two passageways,respectively for passing each of the portions 42 and 44 of the ligature14.

FIGS. 8 to 13B depict various view of one embodiment of the fixingsystem. In these figures, there can be seen the rod 18, the connectingpart 12, and the flexible ligature 14.

In this embodiment, the connecting part 12 is constituted by a part 55that is generally U-shaped. The inside wall of this part 55 isconstituted by a bottom 57 of substantially semicylindrical shape and bytwo substantially plane portions 53 and 54 that correspond to the twolimbs of the part 55. The width of the recess 58 formed in the part 55is substantially equal to the diameter of the rod 18. On its outsideface 59 which is circularly symmetrical about a longitudinal axis of thepart 55, there is provided a thread 60 occupying its upper portion. Thethread 60 is located entirely above the rod 18 when it is put into placein the recess 58. The thread 60 is designed to co-operate with aclamping ring 62 that constitutes the adjustable locking means. Thisring has a slightly frustoconical bore 64 with an inside face 66 thatcarries tapping 68.

In some embodiments, when the ring 62 is screwed tight on the threadedportion 60 of the part 55, it deforms the limbs of the part 55elastically, thereby pinching and clamping strands of the ligature 14between the rod 18 and the inside wall(s) of the recess 58, in a mannerexplained below.

As shown in FIGS. 10 and 11, the part 55 includes in its bottom 70 apassage 72 for passing the ligature 14 in a manner explained below.

With references to FIGS. 12, 13A, and 13B, there follows a descriptionof two different ways of putting the flexible ligature 14 into placeinside the connecting part 12 in the second embodiment. The side wall ofthe rod 18 and the inside wall of the recess 58 of the part 55potentially define two passageways 74 and 76 for passing the middlestrands of the flexible ligature 14. In the configuration shown in FIG.13A, only the passageway 74 is used. Thus, both intermediate portions 42and 44 of the flexible ligature 14 are disposed in the passage 74.

In the configuration shown in FIG. 13B, the middle portions 42 and 44 ofthe flexible ligature 14 are disposed respectively one in each of thepassageways 74 and 76, i.e. on either side of the rod 18.Advantageously, the free ends of the ligature 14 are accessible forexerting the desired traction in order to obtain suitable clamping onthe spinous process prior to locking the clamping ring 62 on the part55.

One advantage to this type of embodiment may be the ability to avoidmaking two longitudinal parts constituting a kind of clamp hinged on thepin 24. In some embodiments, the locking means are constituted by anelement that is distinct from the connecting part and that is removabletherefrom. In some embodiments, the locking means co-operate with theconnecting part by screw engagement. It is thus possible to adjustaccurately the dimensions of the ligature-passing passageway(s) asdefined by the connecting part and the rod. In an initial stage, thecoefficient of friction between the coefficient of the ligature andsecondly the rod and the connecting part can be adjusted. In the finalstage, very effective clamping of the ligature is obtained between therod and the locking part.

In some embodiments, including for example the embodiments shown inFIGS. 14-39, rod 18 may not be needed in order for the bone fixingsystem to effectively hold a bone in a relative position. Theembodiments of the bone fixing system 100 shown in FIGS. 14-39 caninclude conformable ligature 14 and blocking body 120, which may includecompression member 140. In these embodiments that do not require the useof rod 18, the conformable ligature 14 may be passed around one or morebones, tendons, muscles, rods, plates, screws, or other structures in abody and passed through loop passage 126 in blocking body 120 to form aloop extending from a first portion of blocking body 120 and a first endand a second end of conformable ligature 14 may be passed out one ormore exit passages 128 in blocking body 120 to extend in a freeconfiguration from a second portion of blocking body 120. Thus, althoughconformable ligature 14 may, in some uses, pass around rod 18 to capturerod 18 in a loop portion, rod 18 is not necessary for bone fixing system100 to hold a bone in a secure position.

With reference to FIGS. 14-38, in embodiments that do not require theuse of rod 18 to hold a structure in a relative position, bone fixingsystem 100 may include compression member 140 having a first surface 146for contact with conformable ligature 14 and for cooperating with insidesurface 125 of blocking body 120 to form a passageway for one or moreends of conformable ligature 14. Compression member 140 may be insertedinto blocking body 120 before conformable ligature 14 is passed throughblocking body 120. In some embodiments, closure member 130 may engagewith engagement portion 123 of blocking body 120 before insertingcompression member 140 and/or passing conformable ligature 14 throughblocking body 120.

In other embodiments that do not require the use of rod 18 to hold astructure in a relative position, bone fixing system 100 may includeclosure member 130 for engagement with engagement portion 123 ofblocking body 120 and for contact with compression member 140 so thatadvancing closure member 130 into blocking body 120 biases compressionmember 140 onto conformable ligature 14. Closure member 130 may beadvanced into blocking body 120 for biasing compression member 140against conformable ligature 14 to create a friction force betweenconformable ligature 14 and blocking body 120. A friction force betweenconformable ligature 14 and blocking body 120 may hold conformableligature 14 in place without significant movement relative to blockingbody 120. In some embodiments, closure member 130 may be advanced intoblocking body 120 for impinging conformable ligature 14 betweencompression member 140 and blocking body 120 to prevent any relativemovement.

Advantageously, the use of compression member 140 in these embodimentsenable bone fixing system 100 to be used in circumstances in which rod18 may be undesirable or unnecessary. Another advantage of theembodiments illustrate in FIGS. 14-38 is the ability for the surgeon tomore easily see conformable ligature 14 as it is passed through variouspassages in the bone fixing system. Another advantage to this embodimentis the reduced size of blocking body 120 over prior art devices thatcouple to a rod. In particular, the use of compression member 140,particularly having a hemispherical profile, can reduce the height andoverall profile of blocking body 120.

FIG. 14 depicts a cross-sectional view of a portion of one embodiment ofbone fixing system 100 useful for holding a bone in a position withoutrequiring rod 18. Bone fixing system 100 of FIG. 14 includes blockingbody 120 with compression member 140 and closure member 130, ligature14, and tensioning tool 250. Blocking body 120 of FIG. 14 includesclosure member passage 123 for receiving closure member 130 and looppassage 126 and exit passages 128 for receiving ligature 14 throughblocking body 120 (e.g., as shown). As shown in FIG. 14, ligature 14 hasbeen passed through blocking body 120 such that each end 14 of ligature14 extends out of one of exit passage 128 and ligature 14 passes throughloop passage 126 to form ligature loop portion 14. In some embodiments,ligature 14 may have a round profile, which can often provide thehighest strength per unit of cross-sectional area of ligature 14, enablepassing ligature through small openings, and/or reduce the area ofcontact with a structure. As shown in FIG. 14, ligature 14 may have awide, flat (or approximately flat) profile which may distribute forcesover a larger area, provide higher strength, and/or prevent rolling(e.g. as compare to a round profile). Compression member 140 includesfirst surface 146 for cooperating with inner surface 125 of blockingbody 120 to form a passageway between loop passage 126 and exit passages128. As shown in FIG. 14, closure member 130 includes threads 132 forengaging threads 122 in engagement portion 123 of blocking body 120 andbottom surface 135 for contact with compression member 140. As shown inFIG. 14, closure member 130 has been engaged with threads 122 inblocking body 120 and bottom surface 135 contacts compression member 140such that ligature 14 is held in place relative to blocking body 120 dueto compression in the passageways formed by first surface 146 and innersurface 125 between loop passage 126 and exit passages 128. As shown inFIG. 14, bone fixing system 100 includes tensioning tool 250 havingcentral passage 152 for passage of ends 14 of ligature 14 and distal end154 for contact with blocking body 120.

As shown in FIG. 14 (and FIG. 15), blocking body 120 may be manufacturedwith inner surface 125 for cooperating with first surface 146 ofcompression member 140 to form a space through which conformableligature 14 passes and for contacting with a portion of conformableligature 14 to hold conformable ligature 14 in position. In someembodiments, inner surface 125 may be manufactured with a grooved,knurled, or otherwise textured surface to aid in holding conformableligature 14 in place. Inner surface 125 of blocking body 120 may becoated, layered, or otherwise treated to aid in holding conformableligature 14 in place. In some embodiments, inner surface 125 may allowone-way passage of conformable ligature 14 through blocking body 120,for example, by manufacturing inner surface 125 with an asymmetricsaw-tooth profile to allow passage of conformable ligature 14 throughblocking body 120 in a first direction but to resist movement in theopposite direction.

As shown in FIG. 14, loop passage 126 is located along the arclengthopposite (i.e., facing) first surface 146 of compression member 140positioned in blocking body 120, but it should be understood that looppassage 126 could be positioned at other places around blocking body120. As shown in the embodiment of FIG. 14, exit passages 128 arelocated on opposing portions of blocking body 120 and each is locatedhigher than the uppermost portion of compression member 140 whenpositioned in blocking body 120. However it should be understood thatexit passages 128 can be located at other positions around blocking body120. In various embodiments, loop passage 126 and exit passages 128 maybe circular, oval, elliptical, or other shape, may be symmetric orasymmetric, and may be oriented such that conformable ligature 14 mayenter or exit blocking body 120 at an angle, normal, or substantiallytangential to a portion of blocking body 120. In alternativeembodiments, there may only be a single exit passage 128 through whichboth ends 14 of ligature 14 pass.

As shown in FIG. 14, tensioning tool 250 (discussed in further detailbelow) has distal end 154 for detachable engagement with a portion ofblocking body 120. In some embodiments, distal end 154 of longitudinalmember 260 may have passage 152 for accessing closure member 130. Asshown in FIG. 14, distal end 154 may be curved for engagement with aportion of blocking body 120 having a generally curved profile.

In some uses, ligature 14 may have one or both ends passed around astructure in the body. Both ends of ligature 14 may be inserted in looppassage 126 to form a loop around the structures. Compression member 140may be inserted in compression member opening 124. Ligature 14 may bepassed through the passageway formed between first surface 146 ofcompression member 140 and inner surface 125 of blocking body 120. Endsof ligature 14 may be passed out one or more exit passages 128. Closuremember 130 may be inserted in engagement portion 123 to engage threads122. Ends of ligature 14 may be connected to tensioning tool 250, suchas tensioning tool 250 shown in FIG. 39, Ligature 14 may be tightened,and closure member 130 may be inserted in engagement portion 123 andadvanced until closure member 130 contacts compression member 140.Advancing compression member 140 creates a friction force betweenligature 14 and blocking body 120. The friction force may be greatenough to impinge ligature 14 relative to blocking body 120 or may beenough to resist movement of ligature 14 relative to blocking body 120.

FIG. 15 depicts an exploded perspective view of the embodiment ofblocking body 120 shown in FIG. 14, including compression member 140 andclosure member 130. As shown in FIG. 15, blocking body 120 includesengagement portion 123 having threads 122 for receiving closure member130, and compression member opening 124 through which compression member140 may be inserted to “side-load” compression member 140 withinblocking body 120. As shown in the embodiment of FIG. 15, closure member130 includes tool portion 134 and thread 132 and compression member 140includes first surface 146, second surface 145, and flanges 142.

As shown in FIG. 15, blocking body 120 can include compression memberopenings 124 on either side of blocking body 120 for insertion ofcompression member 140. In the embodiment of FIG. 15, compression memberopening 124 has a constant diameter, while in alternative embodimentsopening 124 may have a first diameter large enough to accommodateflanges 142 and a second diameter smaller than flange 142 but largeenough to seat compression member 140. Compression member 140 can beinserted, positioned, and/or removed from blocking body 120. In variousembodiments, compression member 140 may be short enough to fit insideblocking body 120, compression member 140 may be substantially the samelength as blocking body 120, or compression member 140 may extend somedistance beyond blocking body 120. Advantageously, compression member140 enables embodiments of the bone fixing system 100 to operate inareas of the body or in situations in which a rod may be difficult orundesirable. An advantage to blocking body 120 having compression memberopening 124 oriented for side-loading compression member 140 is theability to adjust the positioning of compression member 140 afterclosure member 130 has engaged engagement portion 122.

Extensions 142 (such as flanges 142) of compression member 140 canoperate to prevent compression member 140 from shifting or moving out ofposition once closure member 130 has engaged engagement portion 123 ofblocking body 120. In operation, closure member 130 will contactcompression member 140 to hold ligature 14 substantially in place whenligature 14 has been positioned to hold a bone or other structure in arelative position. In some embodiments, extensions 142 may extend aroundthe entire arclength of first surface 146 of compression member 140,such as flanges 142 depicted in FIG. 15, while in other embodiments,extensions 142 may extend around a portion of the arclength of firstsurface 146. In some embodiments, a radius of extension 142 may allowinsertion or removal of compression member 140 in a first orientationand may prevent removal or insertion in a second orientation. Forexample, in some embodiments, extensions 142 may have a radius to enablecompression member 140 to be inserted into blocking body 120 whencompression member 140 is rotated to a first angle, while preventingcompression member 140 from being removed when compression member 140 isrotated (e.g., 90 degrees) from the first angle. In some embodiments,compression member 140 may have a variable radius.

As shown in the embodiment of FIG. 15, first surface 146 of compressionmember 140 can form a passageway in cooperation with inner surface 125of blocking body 120 for passing ligature 14 and for contactingconformable ligature 14. In some embodiments, first surface 146 may beknurled, grooved, or otherwise machined, may be coated, layered, orotherwise treated for contact with conformable ligature 14, and/or mayallow one-way passage of conformable ligature 14 through compressionmember 140 (e.g., having an asymmetric saw-tooth profile for allowingpassage of conformable ligature 14 past compression member 140 in afirst direction but resisting passage in an opposite direction).

Various mechanisms can be used to allow closure member 130 to engageengagement portion 123 of blocking body 120. In some embodiments,closure member 130 has helically wound thread 132 and can be advanced inblocking body 120 through engagement passage 123 by rotating closuremember 130 to engage threads of engagement portion 123 of blocking body120. In some embodiments, tool portion 134 on closure member 130 can bea hex shaped receiving are that would allow a surgeon to use a hex toolto engage and rotate closure member 130 so that threads 132 engage withthe threads of engagement portion 123. In some embodiments, closuremember 130 may have a sawtooth profile or other profile for ratchetingclosure member 130 into blocking body 120. Those of ordinary skill inthe art will recognize a variety of other mechanisms (some of which willbe described herein) for engaging closure member 130 with engagementportion 123 in order to enable closure member 130 to contact compressionmember 140 and secure in place ligature 14.

Advantages to embodiments of bone fixing systems 100 such as the onedepicted in FIGS. 14 and 15 include the curved profile of blocking body120, which can result in an overall lower profile and/or in less stresson surrounding tissue based on friction contact.

FIG. 16 depicts a perspective view of an alternative embodiment ofcompression member 140 of FIGS. 14 and 15 having longitudinal slot 144and stress reducer 148. In some embodiments, compression member 140 mayhave a length and width such that when compression member 140 ispositioned inside blocking body 120, first surface 146 is in contactwith inner surface 125 of blocking body 120 (or first surface 146 is incontact with conformable ligature 14 which is in contact with innersurface 125 of blocking body 120, for example as shown in FIG. 14). Invarious embodiments, compressing on second surface 145 may bias firstsurface 146 against inner surface 125 and the radius of curvature offirst surface 146 may effectively change some amount, based at least inpart on the length and depth of longitudinal slot 144. One advantage tocompression member 140 having longitudinal slot 144 is the capability toadjust the compressive force exerted by compression member 140 onligature 14. In addition to the length and depth of longitudinal slot144, the amount that the radius of curvature can change can depend onthe compression force applied to second surface 147, the shape of innersurface 125, the deformability of any coating, layer, a machined featureof inner surface 125 or first surface 146, the thickness of conformableligature 14, or the original shape of first surface 146. As shown in theembodiment of FIG. 16, longitudinal slot 144 can include stress reducer148, which can advantageously prevent or reduce the likelihood ofcompression member 140 cracking or other material failure due to achange in curvature of first surface 146. While other shapes can beemployed, stress reducer 148 may be generally circular or othernon-angular shape to prevent the build-up of stresses associated withbending forces. The radius and position of stress reducer 148 may bebased on the material used for compression member 140, the radius ofcurvature of first surface 146, the depth and width of longitudinal slot144, the anticipated compression force applied to second surface 147, orthe length of compression member 140.

FIGS. 17-19 illustrate another embodiment of the bone fixing system 100.FIG. 19 is a perspective view of this embodiment of blocking body 120,in which compression member 140 and closure member 130 may be top-loadedor side-loaded into blocking body 120 via U-shaped channel 127. In thisembodiment, blocking body 120 is shown to include two upwardly extendingwalls forming a generally U-shaped channel 127. Compression member 140is shown with a similar “dual cylinder” shape as the compression member140 of FIG. 16 (in fact, the compression member of FIG. 16 can be usedin the FIG. 17 embodiment) with first surface 146 and flanges 142. Asshown in FIG. 18, compression member 140 may extend some distance beyondblocking body 120 with extensions 142 on compression member 140 designedto prevent compression member 140 from moving laterally once compressionmember 140 is positioned in blocking body 120. As shown in the FIG. 18embodiment, extensions 142 may be located exterior to blocking body 120(while in alternative embodiments, extensions 142 may be locatedinterior to blocking body 120).

Compression member 140 can be placed within channel 127 with surface 146contacting inner wall 125 at the bottom of channel 127. Closure member130 may be inserted into channel 127 (e.g., by engaging the exteriorthreads on the body of closure member 130 with the interior threads ofchannel 127) for engaging engagement portion 122. Advancing closuremember 130 down channel 127 (e.g., rotating closure member 130) canforce compression member 140 against ligature 14 to hold ligature 14 inplace without significant movement (or with complete impingement)relative to blocking body 120.

FIG. 17 shows a cross-sectional view of this embodiment of bone fixingsystem 100 using the blocking body 120 of FIG. 19 in which compressionmember 140 is either side or top-loaded into blocking body 120. As shownin FIG. 17, conformable ligature 14 may be passed through loop passage126 in blocking body 120 to form a loop extending from blocking body 120and first and second ends may be passed out one or more exit passages128 to extend from a second portion of blocking body 120. In order touse the bone fixing system 100 to hold a bone in position, compressionmember 140 may be inserted in blocking body 120 after conformableligature 14 has been passed through blocking body 120. Closure member130 may be engaged to engagement portion 122 of blocking body 120 afterconformable ligature 14 has been passed through blocking body 120 andafter compression member 140 has been positioned in blocking body 120.

Engaging closure member 130 in engagement portion 122 of blocking body120 prevents all or significant movement of conformable ligature 14relative to blocking body 120.

As shown in FIG. 17, exit passages 128 can be positioned higher thanfirst surface 146 of compression member 140 in order to provide a longerpassage between first surface 146 of compression member 140 and innersurface 125 of blocking body 120 to provide a higher frictioncoefficient or reduced point stresses on conformable ligature 14,blocking body 120, and/or compression member 140. In alternativeembodiments, exit passages 128 may be positioned near engagement portion122 such that closure member 130 may contact conformable ligature 14. Invarious embodiments, closure member 130 may impinge a portion ofconformable ligature 14. As shown in FIG. 17, exit passages 128 may belocated on blocking body 120 such that when distal end 154 of tensioningtool 250 engages blocking body 120, first and second ends of ligature 14are external of distal end 154. However, it should be understood thatexit passages 128 may be located at a number of locations on theblocking body 120 and relative to tensioning tool 250. Distal end 154 oftensioning tool 250 may engage a portion of blocking body 120 to enablea surgeon to tension conformable ligature 14 in order to hold a bone orstructure in position. In various embodiments, distal end 154 oftensioning tool 250 may be flanged for engaging blocking body 120.Tensioning tool 250 may include passage 152 along the entire length oftensioning tool 250 for accessing closure member 130 or passage 152 mayextend a selected length of tensioning tool 250.

FIG. 18 depicts a side view of this embodiment of bone fixing system 100where conformable ligature 14 passes through loop passage 126 to form aloop extending from a first portion of blocking body 120, and furtherpasses through a passage formed by compression member 140 and blockingbody 120, and passes out both exit passages 128 (though ligature 14could in various embodiments pass both ends through a single exitpassage 128). FIG. 18 illustrates the flanges 142 extending outside ofblocking body 120.

As described, closure member 130 may be top-loaded into blocking body120 for the embodiments of FIGS. 17-19. One advantage to top-loadingclosure member 130 and compression member 140 is that closure member 130may be integrated with compression member 140 to form a unitary piece,which reduces the number of components that the surgeon has to implantduring surgery. In various embodiments, closure member 130 may beconnected to compression member 140 by a pin (not shown) to form aunitary piece. In some embodiments, closure member 130 may rotate whilecompression member 140 does not rotate. One advantage to this unitaryclosure member/compression member embodiment is that compression member140 may apply only compression forces to ligature 14. In contrast, ifcompression member 140 rotates inside blocking body 120, torsion may beapplied to ligature 14.

FIGS. 20-22 depict yet another embodiment of bone fixing system 100 inwhich conformable ligature may be passed around one or more bones,tendons, muscles, rods, plates, screws, or other structures in the body,and then passed through loop passage 126 in blocking body 120 to form aloop extending from a first portion of blocking body 120. Ligature 14can then be passed through a passageway formed by first surface 146 ofcompression member 140 and inner surface 125 of blocking body 120, andpassed out through the center of blocking body 120 to extend out ofblocking body 120 so that ends 14 of ligature 14 can be in a freeconfiguration. Tensioning tool 250 may have a central passage 152 toallow first end and second end of ligature 14 to pass through.

FIG. 21 depicts a side view of a portion of one embodiment of blockingbody 120, in which compression member 140 may be side-loaded throughcompression member opening 124 into blocking body 120. As shown,blocking body 120 of FIG. 21 has a similar shape to the blocking body120 of FIG. 19, except that the FIG. 21 embodiment of blocking body 120encloses compression member 140 (as opposed to the “open” top of theblocking body 120 of FIG. 19). Thus, in the FIG. 21 embodiment,compression member 140 may be pre-loaded into blocking body 120 or evenmanufactured to be permanently enclosed within blocking body 120. In analternative embodiment, compression member 140 and/or extensions 142 maybe manufactured with dimensions such that once compression member 140 isinserted in blocking body 120, the position of compression member 140may be altered but compression member 140 may not be removed fromblocking body 120. In other words, in the embodiment shown in FIG. 21,compression member 140 may be moved around inside blocking body 120, butmay not be removed. In various embodiments, blocking body 120 may bemanufactured with compression member opening 124 having a first set ofdimensions and after compression member 140 is inserted into blockingbody 120 through opening 124, the size of opening 124 may be altered(e.g., by adding material or altering the shape of blocking body 120 atopening 124) to reduce opening 124 dimension to prevent removal ofcompression member 140. Alternatively, compression member 140 may bemanufactured having a first set of dimensions, inserted into opening 124of blocking body 120, and then altered, such as by adding material, toincrease the dimensions of compression member 140 to prevent removal ofcompression member 140. In various embodiments, compression member 140may be compression fit or sweat-locked through opening 124 into blockingbody 120. In another embodiment, blocking body 120 may be manufacturedwith two upwardly extending walls, compression member 140 may beinserted in a channel formed by the two walls, and material may be addedto convert the channel into opening 124.

FIG. 22 depicts an exploded perspective view of the embodiment ofblocking body 120 of FIGS. 20 and 21 in which compression member 140 maybe side-loaded into blocking body 120 and closure member 130 maythreadably engage engagement portion 122 of blocking body 120. A toolmay engage with tool portion 134 for rotating closure member 130 toengage external threads 132 on closure member 130 with internal threads122 in blocking body 120. Tool portion 134 of closure 130 can be hollowto enable one or more ends of conformable ligature 14 to pass throughand extend out exit passage 128.

FIGS. 23-25 show another embodiment of a bone fixing system 100 havingan alternate closure mechanism and exit passage. FIG. 23 depicts a crosssectional end view of bone fixing system 100 in which conformableligature 14 may be passed through loop passage 126 in blocking body 120to form a loop extending from a first portion of blocking body 120,through a passage formed by first surface 146 of compression member 140and inner surface 125 of blocking body 120, and extend out through exitpassage 128. As shown in FIGS. 23 and 25, in this embodiment, ring-styleclosure member 130 may have internal threads 132 for engaging externalthreads 122 on blocking body 120. This type of embodiment will providethe advantage of allowing the surgeon to see conformable ligature 14 asit passes through loop passage 126 in blocking body 120 and to seecompression member 140 as it is positioned in blocking body 120.

FIG. 24 depicts a side view of the FIG. 23 embodiment in which bottomsurface 135 of closure member 130 is in contact with second surface 145of compression member external to blocking body 120, and in thisembodiment bottom surface 135 of closure member 130 contacts secondsurface 145 at extensions 142 of compression member 140. An advantage tothis type of embodiment is the ability for the surgeon to see theengagement between threads 132 on closure member 130 with threads 122 onblocking body 120. As shown in FIG. 24, tool portions 134 of closuremember 130 may be positioned on an exterior portion of closure member130. An advantage to this type of embodiment is the ability for a tool(not shown) to engage tool portions 134 exterior to distal end 154 (notshown) engaged with a portion of blocking body 120. This exteriorengagement can provide a superior tightening mechanism to engage closuremember 130 with blocking body 120 in certain embodiments.

FIG. 25 depicts an exploded perspective view of the FIG. 24 view withthe various portions of blocking body 120 separated prior to engagementof closure member 130 onto blocking body 120. An advantage to thisembodiment is the reduced number of passages, which may reduce the timeneeded to implant the system.

FIGS. 26-28 illustrate an alternative embodiment of bone fixing system100 that provides a hinged closing mechanism offset from ligature 14that also does not require a rod, and which can provide certainadvantages over other embodiments. FIG. 26 shows blocking body 120 withfirst portion 170 hingedly connected via hinge pin 178 to second portion180. Conformable ligature 14 can pass through loop passage 126 in firstportion 180 of blocking body 120 to form a loop extending from firstportion 180 of blocking body 120, further passed through a passageformed between first surface 146 of compression member 140 and innersurface 125 of blocking body 120, and then passed through exit passage128 in second portion 170. As with every embodiment described, ligature14 may get to this desired configuration (with a loop portion extendingfrom blocking body 120) in a variety of ways. An advantage to thisembodiment is the low profile possible due to the configuration ofclosure member 130 offset from compression member 140.

In various embodiments, hinge pin 178 connects first portion 170 tosecond portion 180 in either a permanent manner or alternatively thehinged connection may be disconnectable. The hinged connection can beformed so as to allow two-way hinged motion for engaging or disengagingfirst portion 170 from second portion 180. In an alternative embodiment,the hinged connection may allow one-way hinged motion for engaging firstportion 170 from second portion 180 but may subsequently prevent firstportion 170 from disengaging second portion 180. In various embodiments,first portion 170 and/or second portion 180 may allow hinged motionbetween a selected arclength, for example, first portion 170 and secondportion 180 may move through an arc of approximately 180 degrees.

As further shown in FIGS. 26-28, closure member 130 will be used toclose the hinged bone fixing system 100 in a manner to hold ligature 14in a relatively or completely stable position relative to blocking body120. Closure member 130 of FIG. 27 is shown having external threads 132for engaging internal threads 122 in engagement portion 123 of blockingbody 120. Second portion 180 may include engagement portion 122 forengagement by threads 132 on closure member 130. In one embodiment,closure member 130 may be positioned within first portion 170 such thatclosure member 130 is free to rotate in first portion 170 to join firstportion 170 with second portion 180, but may not be removed from firstportion 170 after such engagement. In other words, in some embodiments,closure member 130 may be rotated to engage threads on closure member130 with engagement portion 122 to collapse first portion 170 and secondportion 180, and the direction of rotation may be reversed to disengageclosure member 130 from engagement portion 122, but closure member 130may not be removed from first portion 170. In the embodiment shown inFIG. 26, closure member 130 can be rotatably positioned in secondportion 180 such that closure member 130 is free to rotate in secondportion 180 but may not be removed from second portion 180, which canprovide the advantage of reducing the risk of having loose hardware(which can be lost inside a patient during surgery) associated with bonefixing system 100.

FIG. 27 depicts a cross-sectional side view of a portion of theembodiment of bone fixing system 100 depicted in FIG. 26, in whichconformable ligature 14 may be passed through loop passage 126 in firstportion 170 to form a loop extending from first portion 170 of blockingbody 120, passed through a passage formed by first surface 146 ofcompression member 140 and inner surface 125 of blocking body 120, andextend from exit passage 128 in second portion 180. As shown in FIG. 27,first portion 170 and second portion 180 rotate about hinge pin 178 toopen or close blocking body 120. Tool portion 134 on closure member 130may be rotated so threads 132 on closure member 130 engage threads 122in engagement portion 123. Once bottom surface 135 of closure member 130reaches a selected point, first portion 170 and second portion 180compress to impinge movement of ligature 14 relative to blocking body120.

First surface 146 of compression member 140 and inner surface 125 ofblocking body 120 provide a passageway through blocking body 120. Insome embodiments, inner surface 125 may be located on first surface 170and first surface 146 of compression member 140 may be located on secondportion 180 as depicted in FIG. 27. In some embodiments, inner surface125 may be located on second surface 180 and first surface 146 ofcompression member 140 may be located on first portion 170.

Closure member 130 may be offset from compression member 140 such thatthreaded engagement of threads 132 of closure member 130 with engagementportion 122 of blocking body 120 may indirectly apply compression tocompression member 130. In other words, compression member 140 may bepositioned some distance L.sub.b from hinge pin 178 and closure member130 may be positioned some distance L.sub.s from hinge pin 178.Compression of compression member 140 onto conformable ligature 14 maynot be accomplished by directly contacting bottom surface 135 of closuremember 130, but may instead be accomplished by rotatably engagingthreads 132 with threads 122 to advance closure member 130 in blockingbody 120 such that second portion 180 may be leveraged around thefulcrum created by hinge pin 178. An advantage to one embodiment usesthe mechanical advantage of L.sub.s/L.sub.b to apply compression forceson conformable ligature 14. Another advantage to one embodiment is theability for the surgeon to apply large compression forces to conformableligature 14 due to the mechanical advantage based on the position ofhinge pin 178, compression member 140, and closure member 130. Thecompression forces available may also be based on the radius ofcurvature of compression member 140, the size or pitch of threads 132and 122, and/or the size of hinge pin 178. Another advantage may be theprecision in which a friction coefficient may be selected betweenconformable ligature 14 and blocking body 120. In some embodiments, thepitch, shank diameter, or other dimensions of closure member 130 mayenable control of the application of compression. For example, a largenumber of threads per inch may allow more compression due to themechanical advantage of threads 122 engaging with threads 132, and theapplication may be more controlled due to the greater angular rotationneeded to advance closure member 130 the same distance as closuremembers 130 having lower numbers of threads per inch. Another advantageto this embodiment relates to the outer surface of first portion 170and/or second portion 180. Because blocking body 120 can achieve amechanical advantage through the use of hinge pin 178, closure member130 may be made smaller than prior art approaches, which allows blockingbody 120 to have a smaller opening 123. As shown in FIG. 27, secondportion 180 has an outer surface that is curved, which may reduce pain,discomfort, or other undesirable effects that result from using anangular implant.

FIG. 28 depicts a perspective view of the embodiment of FIGS. 26 and 27shown in a closed configuration, where ligature 14 is held completely orsubstantially in place relative to blocking body 120. One advantage tothis type of embodiment may be the ability to pass conformable ligature14 around one or more bones, tendons, muscles, rods, plates, screws, orother structures in the body, pass conformable ligature 14 throughblocking body 120 out a single exit passage 128, and engage closuremember 130 on blocking body 120, but offset from conformable ligature 14and/or compression member 140. One advantage may be that tensioning tool250 may not need passage 152 in distal end 154 because closure member130 (e.g., tool portions 134) may be accessed outside tensioning tool250.

It should be understood that the various closure mechanisms, closuremembers, exit passages, and blocking bodies, and other design featuresshown in the various embodiments of bone fixing system 100 of FIGS.14-28 may potentially be used in the other embodiments of FIGS. 14-28.For example, the ring-style closure member 130 of the FIG. 25 embodimentcan be used on the embodiment of FIG. 22 by modifying the blocking bodyof FIG. 22 to have external threads onto which the internal threads ofthe ring-style closure member 130 would engage.

FIGS. 29-38 depict embodiments of bone fixing system 100 in variousconfigurations, arrangements and orientations. In FIGS. 29-38, theembodiment of blocking body 120 is the embodiment depicted in FIGS.26-28. However, any of the embodiments depicted in FIGS. 14-28 andvariations may be used without departing in scope from the presentdisclosure.

FIG. 29 depicts a perspective view of one embodiment of bone fixingsystem 100 for holding a bone in a position. Bone fixing system 100 maybe useful for orthopedic applications, such as holding a bone near atendon or muscle. Portions 214 of conformable ligature 14 may be passedthrough or around a portion of a muscle and through or around a portionof a femur to provide support while a tear or cut in the muscle heals.Advantageously, blocking body 120 may be positioned at various locationsnear the muscle, tendon, or bone based on the type or extent of theinjury, trauma, or illness, surgical preferences such as MIS access, orpatient health such as age or weight, or the like Advantageously,embodiments of bone fixing system 100 may be implanted near othersurgical implants without affecting their placement or function. Invarious embodiments, bone fixing system 100 may include blocking body120 indirectly applying tension to conformable ligature 14. For example,in the embodiment depicted in FIG. 29, bone fixing system 100 may beimplanted to maintain bone 219 in a position with muscle 209 while wound211 heals. In this embodiment, conformable ligature 14 may be passedaround bone 219 and through muscle 209, and through blocking body 120located on portion 112 of conformable ligature 14 such thatsubstantially all tension between muscle 209 and bone 219 may besupported by portion 111 of conformable ligature 14.

Bone fixing systems 100 may be implanted without affecting plates, rods,or other implanted structures. Bone fixing systems may be implantedwithout affecting bone screws, hooks, bolts, or other implantedhardware. FIG. 30 depicts one embodiment of conformable ligature 14passed around a part of bone 219, muscle 209 and/or tendon 213 andthrough blocking body 120, and further depicts bone screw 212 and plate210 implanted on a portion of bone 219. In this type of embodiment, bonefixing system 100 including blocking body 120 may be positioned onportion 111 of conformable ligature 14 such that some of the tensionbetween muscle 209 and bone 219 may be supported by blocking body 120.

Bone fixing system 100 may be advantageous for correcting alignment ofone or more bones. Conformable ligatures 14 and blocking bodies 120 maybe useful for correcting alignment of a portion of the spine. FIGS. 31and 32 depict posterior and sagittal views of a portion of the spine inwhich bone fixing system 100 may be useful for aligning vertebra L5 withadjacent vertebrae L4 and sacrum S. In some embodiments, bone fastenerassemblies 212 may be implanted in lumbar vertebra L4 and sacrum S. Insome embodiments, bone fastener assemblies 212 may be inserted throughan incision in the skin and implanted using Minimally Invasive Surgery(MIS) techniques, and ligature 14 may be passed around one or morestructures.

In some embodiments, passing may include going into, through, or out ofa structure. In some embodiments, passing may include going over, under,or around a structure. In some embodiments, passing may include crossingover other ligatures 14 or portions of ligatures 14. In someembodiments, passing may include multiple passes along the same pathFIGS. 33-38 depict various embodiments of bone fixing systems in placeon a portion of a spine. In FIGS. 33-38, bone fixing system 100 is shownholding bone graft 230, which may be useful for supporting a portion ofthe spine. However, embodiments of bone fixing system 100 may be used tocorrect problems with the spine without rods, bone grafts, plates, orother implants. Conformable ligature 14 may be passed around a portionof a bone, such as spinous process SP Conformable ligature 14 may bepassed around a portion of bone graft 230. Passing conformable ligature14 around a portion of bone graft 230 may include passing a portion ofconformable ligature 14 through a portion of bone graft 230. One end ofconformable ligature 14 may be inserted and passed through blocking body120 from one side and the other end of conformable ligature 14 may beinserted and passed through blocking body 120 from another side, asdepicted in FIG. 33.

Advantageously, conformable ligature 14 may be selectively passed aroundstructures such as bones and bone grafts. Conformable ligature 14 may bepassed around a bone, bone graft, tendon, or other tissue due todisease, injury, tumor, degenerative effects or the like. For example,FIG. 33 depicts a posterior view of one embodiment in which conformableligature 14 may be passed around a portion of spinous process SP onlower vertebra L5. FIG. 33 further depicts one embodiment in whichconformable ligature may be passed through bone, such as the pedicle oflower vertebra L5. As another example, FIG. 34 depicts a sagittal viewof one embodiment in which conformable ligature 14 may be passed aroundthe posterior portion of spinous process SP. As another example, FIG. 35depicts a posterior view of one embodiment in which conformable ligature14 may be passed around a portion of the pedicle portion of lowervertebra L5. As another example, FIG. 36 depicts a sagittal view of oneembodiment in which conformable ligature 14 may be passed around thepedicle portion and the posterior portion of spinous process SP. In someembodiments, ligature 14 may not be passed around a structure FIG. 37depicts a posterior view of one embodiment in which conformable ligature14 may be passed around a portion of the pedicle portion of lowervertebra L5 and the transverse process of upper vertebra L4 but not thespinous process for either vertebra FIG. 38 depicts a sagittal view ofone embodiment in which conformable ligature 14 may be passed around thepedicle portion and through the posterior portion of spinous process SPon lower vertebra L5.

In some embodiments, the surgeon may pass conformable ligature 14alternative ways due to disease, injury, tumor, degenerative effects orthe like. For example, FIG. 33 depicts a posterior view of oneembodiment in which conformable ligature 14 may be passed through aportion of the pedicle of lower vertebra L5, which may allow system 100to apply direct tension on lower vertebra L5. As another example, FIG.34 depicts a sagittal view of one embodiment in which conformableligature 14 may be passed around bone graft 230 and spinous process SPon lower vertebra L5 such that the lower portion of bone graft 230 maybe prevented from moving posterior to the spine but may move anterior tothe spine FIG. 35 depicts a posterior view of one embodiment in whichconformable ligature 14 may be passed around a portion of the pedicleportion of lower vertebra L5, which may allow system 100 to indirectlyapply tension on lower vertebra L5. FIG. 36 depicts a sagittal view ofone embodiment in which conformable ligature 14 may be passed aroundbone graft 230 and spinous process SP on lower vertebra L5 such that thelower portion of bone graft 230 may be prevented from moving posterioror anterior to the spine. FIG. 37 depicts a posterior view of oneembodiment in which first and second conformable ligatures 110 may bepassed around a portion of the pedicle portion of lower vertebra L5.Advantageously, the system 100 may be able to selectively apply tensionto either side of the spine. Furthermore, system 100 may be able tocontrol movement between vertebrae L4 and L5 similarly to theembodiments depicted in FIGS. 33 and 34, but without contacting thespinous process SP of lower vertebra L5. FIG. 38 depicts a sagittal viewof one embodiment in which conformable ligature 14 may be passed aroundthe pedicle portion and through the posterior portion of spinous processSP on lower vertebra L5. Advantageously, vertebrae L4 and L5 may be ableto move relative to each other but bone graft 230 may be held in place.

An advantage to bone fixing system 100 is that the position of blockingbody 120 may be based on disease, injury, tumor, degenerative effects orthe like. For example, FIG. 33 depicts one embodiment in which a singleblocking body 120 may be positioned off-center of the spine. As anotherexample, FIG. 34 depicts one embodiment in which blocking body 120 maybe positioned abutting a bone such as spinous process SP. FIG. 35depicts one embodiment in which blocking body 120 may be positionedcentered on the midline of the spine. FIG. 36 depicts one embodiment inwhich blocking body 120 may be positioned some distance away fromspinous process SP. FIG. 37 depicts one embodiment in which two blockingbodies 120 may be positioned lateral to bone graft 230 FIG. 38 depictsone embodiment in which blocking body 120 may be positioned centeredbetween spinous processes SP.

Two or more conformable ligatures 14 and/or two or more blocking bodies120 may be used to hold a bone, bone graft, tendon, rod, shaft, or otherstructure in a body. FIG. 36 depicts a posterior view and FIG. 37depicts a sagittal view of one embodiment of a bone fixing system havingtwo blocking bodies 120 and 120′ and two conformable ligatures 14 and14′. In some embodiments, bone fixing system 100 may include a firstconformable ligature 14 passed around a bone such as transverse processTP on lumbar vertebra L4 and transverse process TP on lumbar vertebraL5, and a second conformable ligature 14′ passed around a bone such astransverse process TP on lumbar vertebra L4 and transverse process TP onlumbar vertebra L5. Bone fixing system 100 with a first blocking body120 on a first side of the spine and a second blocking body 120′ on thesecond side of the spine may be used to straighten a spine. For example,tensioning one conformable ligature 14 greater than conformable ligature14′ may bias vertebrae to help straighten a curved spine.

FIG. 39 depicts a side view of a portion of one embodiment of tensioningtool 250, which may be used to apply tension to conformable ligature 14.As shown in FIG. 39, tensioning tool 250 includes tool body 266 forengaging conformable ligature 14, longitudinal member 260 foradvancement in tool body 266, and distal end (such as distal end 154depicted in FIGS. 14, 17, and 20) for engagement with blocking body 120.As shown in FIG. 39, tool body 266 includes attachment point 274 (withflange 258) for connection to ligature 14, fixed handle 254, movablehandle 252 for rotation about axis 256, return spring 262, catchmechanism 264, return spring adjustment member 270, and springadjustment member 268.

Attachment point 274 can attach first and second ends of conformableligature 14 to tensioning tool 250. In some embodiments, attachmentpoint 274 may include flange 258 for preventing first and second ends ofconformable ligature 14 from detaching from tensioning tool 250. Distalend 154 (such as the embodiments shown in FIGS. 14, 17, and 20) oftensioning tool 250 may engage to a portion of blocking body 120. Fixedhandle 254 may be gripped by a surgeon, movable handle 252 may berotated about axis 256, such as by squeezing movable handle 252, tolongitudinal member 260 through tool body 266 a selected distance.Advancing longitudinal member 260 to move blocking body 120 away fromtool body 266 while maintaining first and second ends of conformableligature 14 on attachment point 274 applies tension to conformableligature 14. In some embodiments, the selected distance longitudinalmember 260 advances through tool body 266 may be proportional to thetension applied to conformable member 110.

In some embodiments, tool body 266 may include return spring 262, catchmechanism 264, and return spring adjustment member 270 for controllingthe distance that longitudinal member 260 is allowed to return whenmovable handle 252 is released. In some embodiments, return spring 262may bias catch mechanism 264 such that movement is permitted in onedirection only. In some embodiments, return spring 262 may bias catchmechanism 264 such that longitudinal member 260 may only move forwardthrough tool body 266. Advantageously, return spring 262 may ensure thata surgeon does not inadvertently relieve tension from conformableligature 14. In other words, tensioning tool 250 may have a defaultconfiguration for tensioning conformable ligature 14. In someembodiments, actuating catch mechanism 264 (such as a surgeon pressingon catch mechanism 264 with a thumb) may change the positioning of catchmechanism 264 such that movement of longitudinal member 260 is permittedin a reverse direction as well. In some embodiments, movement oflongitudinal member 260 in a reverse direction may include changing thepositioning of catch mechanism 264 in relation to longitudinal member260 as well as pulling in a reverse direction on grasping member 272.

In some embodiments, tensioning tool 250 may include spring adjustmentmember 268 for adjusting the compression on a spring (not shown) in body266. In some embodiments, rotating spring adjustment member 268 onedirection, spring adjustment member 268 may be advanced some distanceinto body 266 such that a spring may be compressed. In some embodiments,rotating spring adjustment member 268 in the other direction, springadjustment member 268 may be advanced some distance out of body 266 suchthat compression forces on the spring may be relieved. By changing thecompression forces on the spring, the spring may exert more or lessforce on longitudinal member 260, which may affect how much tension canbe applied to the ends of conformable ligature 14.

In some embodiments, ligature 14 may be passed around elongate members210, bone fastener assemblies 212, vertebrae (such as L5), and othertendons, muscles, plates or other anatomical or implanted structures andthe ends of ligature 14 may be passed into a portion of blocking body120, such that a loop is formed extending from a first portion ofblocking body 120. In some embodiments, first and second ends ofligature 14 may be passed through a passage in blocking body 120. Insome embodiments, a passage may be formed by inner surface 125 ofblocking body 120 and first surface 146 of compression member 140. Insome embodiments, first and second ends of ligature 14 may exit bypassing out of one or more exit passages 128 in blocking body 120.

Distal end 154 of tensioning tool 250 engages blocking body 120. In someembodiments, distal end 154 of longitudinal member 260 may conform tothe shape or profile of blocking body 120. In some embodiments, distalend 154 of longitudinal member 260 may be configured with features forengaging one or more features on blocking body 120. In some embodiments,first and/or second ends of ligature 14 may be attached to tensioningtool 250. In some embodiments, first and/or second ends of ligature 14may be attached to attachment point 274 located on tool body 266. Insome embodiments, movable handle 252 of tensioning tool 250 may berotated about axis 256 to advance longitudinal member 260 through toolbody 266. The advancement of longitudinal member 260 through tensioningtool 250 moves attachment point 274 away from blocking body 120, pullingends of ligature 14 to decrease the size of the loop, and furtheradvancement tensions ligature 14. In some embodiments, the tensionapplied to ligature 14 may be sufficient to hold one or more structuresin a desired position. In some embodiments, the tension applied toligature 14 may be sufficient to hold a bone in a position. In someembodiments, the tension applied to ligature 14 may be sufficient topull one or more bones or structures into alignment. For example,tensioning tool 250 may provide sufficient tension to one or more endsof ligatures 14 (depicted in FIG. 31) to pull vertebra L5 (depicted inFIG. 32) in alignment with the natural curvature of the spine.

In some embodiments, once an appropriate tension has been applied toligature 14, closure member 130 may be actuated to create a frictionforce to restrict movement of ligature 14 relative to blocking body 120,or to impinge ligature 14 in blocking body 120. In some embodiments,closure member 130 may be pre-installed in blocking body 120. In someembodiments, closure member 130 may be inserted in blocking body 120after engagement of blocking body 120 by tensioning tool 250. In someembodiments, closure member 130 may be inserted through distal end 154of longitudinal member 260 into blocking body 120.

In some embodiments, once closure member 130 has engaged threads 122 inblocking body 120 to provide a desired friction force to impingeligature 14 in blocking body 120, first and second ends of ligature 14may be disconnected from tensioning tool 250. Once ligature 14 has beendisconnected from tensioning tool 250, tensioning tool 250 may bedisengaged from blocking body 120.

The tensioning tool of FIG. 39 can use a ratcheting motion to advancelongitudinal member 260. Each time the surgeon squeezes handles 252 and254 together, longitudinal member 260 advances a predefined distance,typically greater than 10 mm. While tensioning tool 250 works well insurgical procedures, it has several shortcomings. Because longitudinalmember 260 advances the same amount with each pull of handle 252, thesurgeon must tension ligature 14 in relatively large increments, butcannot tension ligature 14 to a position between the increments. Inother words, tensioning tool 250 does not offer a full range oftensioning control as the attachment point can only be positioned at theincrements determined by the ratcheting mechanism (e.g., every 10 mm orso). A corollary of this problem is that tension is applied in a pulsedmanner to ligature 14 as the surgeon squeezes and releases the handles.

Another issue with tensioning tool 250 is that it is difficult for asurgeon to release a selected amount of tension in ligature 14. If asurgeon believes that ligature 14 has been over tensioned, the surgeonmust typically release all or a large amount of tension in ligature 14and begin tensioning ligature 14 again.

Moreover, tensioning tool 250 is relatively bulky. This makes itdifficult to have multiple tensioning tools in place at the same timeduring a procedures. Consequently, tensioning multiple ligatures can betake a significant amount of time as the tensioning tool 250 may have tobe removed from a surgical site each time a surgeon wishes to tension anew ligature. This especially inefficient in procedures in which asurgeon may wish to tension each ligature a little at a time rather thantensioning one ligature completely, then moving to the next ligature.

FIG. 40 is a diagrammatic representation of another embodiment of atensioning tool 300 for tensioning a conformable ligature that overcomesthe shortcomings of tensioning tool 250. Tensioning tool 300 comprises atool body 305, a threaded drive shaft 310 and a movable carriage 315engaged with the threads of drive shaft 310. The threads of drive shaft310 can include any suitable thread shape including a symmetricv-thread, square thread, British acme thread, worm thread, buttressthread, metric acme thread or other suitable thread. Preferably, driveshaft 310 has a thread pitch of between 1-5 mm. Movable carriage 315 isengaged with the threads of drive shaft 310 and moves along slot 320 intool body 305 when drive shaft 310 rotates, Slot 320 can partiallyoverlap carriage 315 to capture carriage 315 in slot 320. In otherembodiments, carriage 315 can be held in place by drive shaft 310.Carriage 315 carries tensioning member 325 that acts as an attachmentpoint for a conformable ligature. Tensioning tool 300 further includes ahandle that provides an ergonomic user control to rotate drive shaft310. According to one embodiment, the handle can connect to drive shaft310 using a quick connect 330. In other embodiments, the handle may befixed. Preferably, all portions of tensioning tool are formed ofbiocompatible material such as stainless steel, titanium, a strongplastic or other material.

Tensioning tool 300 also includes a connector 335 shaped to interfacewith a ligature capturing implant (e.g., such as the connection partsshown in FIGS. 1-13 and blocking bodies shown in FIGS. 14-38). Connector335 can be shaped to abut a variety of ligature capturing implants orconnector 335 can be interchangeable such that a surgeon can select theappropriate interface member based on the type(s) of ligature capturingimplants used in a particular procedure. According to one embodiment,connector 335 can simply abut the ligature capturing implant (includingabutting a rod if the ligature capturing implant uses a rod) or,according to other embodiments, may attach to the ligature capturingimplant. Connector 330 can include tangs 340 that define an open area345 through which the ends of the conformable ligature can pass so thata portion of conformable ligature can be looped around tensioning member325.

FIG. 41 is a diagrammatic representation of a cross section of oneembodiment of tensioning tool 300 showing tool body 305, drive shaft310, carriage 315, tensioning member 325, quick connect 330 andconnector 335. While various components such as body 305 and drive shaft310 are each shown as being single pieces, they may comprise multipleparts. For example, drive shaft 310 can include a threaded portion thatconnects to a non-threaded portion. As another example, tool body 305may comprise multiple pieces.

As illustrated in FIG. 41, carriage 315 defines a threaded passage 355that engages the threads of drive shaft 310. As drive shaft 310 rotates,carriage 315 will move either towards or away from connector 335 alongslot 320 depending on the direction of rotation of drive shaft 310. Inthe embodiment of FIG. 41, rotation occurs about an axis that issubstantially parallel to the primary direction of movement oftensioning member 325. The tension in a conformable ligature loopedabout or otherwise attached to tensioning member 325 will increase ordecrease depending on the direction of rotation. Tensioning member 325may include flange 360 for preventing the conformable ligature fromdetaching from tensioning tool 300.

Tensioning tool 300 further includes a handle that provides an ergonomicuser control to rotate drive shaft 310. According to one embodiment, thehandle can connect to drive shaft 310 at quick connect 330. At the otherend, drive shaft 310 can rest in a drive shaft seat 364 that is movablein tool body 305. A spring 365 between drive shaft seat 364 and toolbody 305 allows drive shaft 310 to be pushed towards connector 335. Thiscan dampen forces applied to the drive shaft towards connector 335(e.g., by the surgeon inadvertently pushing on then handle).Furthermore, since spring 365 will have a known displacement per unitforce applied, a measure of displacement of spring 365 indicates howmuch tension is applied to the ligature (i.e., the force from thetensioned ligature is transferred through carriage 315 to drive shaft310 to compress spring 365 a known displacement). According to oneembodiment, tensioning tool 300 can include features (such as extensions366) that are coupled to the drive shaft. Extensions 366 move forward asdrive shaft 310 moves forward when spring 365 compresses. The positionof extensions 366 can be compared to markings on body 305 to determinethe force applied to the ligature. Preferably, spring 365 is selected sothat spring 365 is fully compressed at between 500 Newtons and 1500Newtons.

In operation, a surgeon can form a loop about one or more structureswith a conformable ligature and a ligature capturing implant Examples ofligature capturing implants are shown in FIGS. 1-28, though any ligaturecapturing implant known or developed in the art can be used, Examples ofa conformable ligature looped about one or more structures are shown inFIGS. 29-38. The structures can include bones, rods and other structuresin a patient's body. Initially, the surgeon can configure the ligaturecapturing implant to allow tightening of the ligature. Another portionof the ligature can be coupled to tensioning tool 300 at tensioningmember 325. According to one embodiment, the conformable ligature isattached by creating a loop with the free ends of the ligature (e.g.,such as ends 42 and 44 of FIG. 6C). This can be done using pins,brackets, metal attachments, sewing, a knot, a clamp or other mechanismfor forming the free ends into a loop. In other embodiments, theconformable ligature may be clamped to a portion of tool 300 orotherwise attached to tool 300.

Before or after attaching the ligature to tensioning member 325, thesurgeon can bring connector 335 into contact with the ligature capturingbody so that connector 335 pushes against the ligature capturing body asthe ligature is tensioned. Rotating drive shaft 310 causes carriage 315to move along slot 320. As carriage 315 moves, a portion of theconformable ligature is pulled causing the loop about the variousstructures to tighten. When the surgeon determines that the ligature issufficiently tightened about the structures to be fixed, the surgeon cantighten the ligature capturing implant so that the ligature does notmove within the ligature capturing implant thereby securing the loopabout the structures. In other embodiments, the ligature capturingimplant may be configured to allow the ligature to be tightened but notloosened. Consequently, once the surgeon is satisfied with the tensionin the loop, the surgeon does not have to further adjust the ligaturecapturing implant to prevent loosening of the loop. Preferably,tensioning tool 300 can apply a tensioning force of at least between 300and 1500 Newtons to the conformable ligature.

When the loop about the structures is secure, the surgeon can rotatedrive shaft 310 in the opposite direction to move carriage 315 towardsconnector 335. This will release the tension from the portion of theligature between tensioning member 325 and the ligature capturingimplant to allow the surgeon to remove the tensioning tool 300.

The embodiment of FIGS. 40 and 41 provides several advantages over theembodiment of FIG. 39. First, the movement speed and placement ofcarriage 315 can be finely controlled by controlling rotation of driveshaft 310. This allows the surgeon to have continuous control over thetensioning process and greater control over the final tension of theligature when compared to the pulsed tensioning provided by theembodiment of FIG. 39. Furthermore, the surgeon can easily reduce thetension in the ligature by small, controllable amounts simply byrotating drive shaft 310 in the opposite direction. Consequently, if thesurgeon deems that the ligature is too tight, the surgeon can rotatedrive shaft 310 in the appropriate direction until the ligature is atthe appropriate lower tension. This is a simpler process than having torelease a relatively large amount of tension and then retention theligature to the desired tension.

Another advantage is provided in procedures in which multiple ligaturesare being installed. In some cases, surgeons find it desirable ornecessary to use multiple ligatures. In such procedures, the surgeonwill often want to tension each ligature a little at a time. Forexample, if there are three ligatures, the surgeon will tension thefirst ligature a small amount, then tension the second ligature a smallamount, then tension the third ligature a small amount, then return tothe first ligature and tension it some more and so on until all theligatures are tensioned the appropriate amount. The embodiments of FIGS.40 and 41 provide an advantage for this type of procedure because theyare less bulky. This allows tensioning tool 300 to be left in placeduring a procedure so that the surgeon can tension other ligatures withother similar tensioning tools without removing tensioning tool 300.Consequently, multiple tensioning tools can be during a procedure toprogressively tension a number of ligatures. Thus, efforts can bedivided along the spine during a reduction procedure so that reductionis continuous.

FIGS. 42A and 42B illustrate another embodiment of a tensioning tool300. Tensioning tool 300 comprises a tool body 305 and a threaded driveshaft 310. A movable carriage 315 is engaged with the threads of driveshaft 310 and moves along slot 320 in tool body 305. Slot 320 canpartially overlap carriage 315 to capture carriage 315 in slot 320. Inother embodiments, carriage 315 can be held in place by drive shaft 310.Carriage 315 carries tensioning member 325 that acts as an attachmentpoint for a conformable ligature. Tensioning tool 300 further includes ahandle that provides an ergonomic user control to rotate drive shaft310. According to one embodiment, the handle can connect to drive shaft310 using a quick connect 330.

Tensioning tool 300 also includes a connector 335 shaped to interfacewith a ligature capturing implant (e.g., such as the connection partsshown in FIGS. 1-13 and blocking bodies shown in FIGS. 14-38). Connector335 can be shaped to abut a variety of ligature capturing implants orconnector 335 can be interchangeable such that a surgeon can select theappropriate interface member based on the type(s) of ligature capturingimplants used in a particular procedure. According to one embodiment,connector 335 can simply abut the ligature capturing implant or,according to other embodiments, may attach to the ligature capturingimplant Connector 330 can include tangs 340 that define an open area 345through which the ends of the conformable ligature can pass so that aportion of conformable ligature can be looped around tensioning member325.

FIGS. 42A and 42B further show extensions 366 that can move in slot 420as drive shaft 310 moves (e.g., due to compression of spring 365 shownin the embodiment of FIG. 40). The position of extensions 366 can beused to determine the amount of force applied to the spring and hencethe ligature.

In the embodiment of FIG. 42A, carriage 315 includes a portion 370 thatis exterior to tool body 305. This portion can allow a surgeon to moreeasily grasp carriage 315 with fingers or a tool to allow the surgeon tomanipulate carriage 315. This can be advantageous in embodiments such asshown in FIGS. 43A and 43B in which the orientation of the carriage canbe changed to engage or disengage carriage 315 from drive shaft 310.

FIG. 42B is a diagrammatic representation of tensioning tool 300 withhandle 375 attached Handle 375 provides an ergonomic interface for asurgeon to rotate drive shaft 310 and may be detachable or fixed. If thehandle is detachable, a kit for tensioning tool 300 can include avariety of handles to allow a surgeon to select a preferred handle 375.In other embodiments, a motor may attach to drive shaft 310 to allow formotorized rotation of drive shaft 310.

FIGS. 43A and 43B are diagrammatic representations of a view of carriage315 carrying tensioning member 325 in a first orientation (FIG. 43A) anda second orientation (FIG. 43B) relative to drive shaft 310. Carriage315 includes a drive shaft passage 355 through which drive shaft 310.Drive shaft passage can completely or partially encircle drive shaft310. In the embodiments of FIGS. 43A and 43B, drive shaft passage 355includes thread engaging portions 380 and unthreaded portions 385. Driveshaft passage 355 can be shaped and sized such that carriage 315 canrock slightly to selectively engage or disengaged thread engagingportions 380 with threads on drive shaft 310. According to oneembodiment, the center of mass of carriage 315 can be positioned so thatcarriage 325 naturally rests in the orientation of FIG. 43A with threadengaging portions 380. In any case, when force is applied to tensioningmember 325 by a tensioned ligature, carriage 315 will tend to rotate toengage thread engaging portions 380. Carriage 315 can be rotatedslightly to disengage thread engaging portions 380. This can allow auser to easily slide carriage 315 to a desired position. For example, auser can apply force by hand or with a tool to portion 370 to rotatecarriage 315 from the position shown in FIG. 43A to the position shownin FIG. 43B to slide carriage 315 in either direction along drive shaft310.

The ability to selectively disengage thread engaging portions 380 sothat the user can slide carriage 315 may make the various portions ofthe tensioning procedure more efficient. Rather than having to rotatedrive shaft 310 to move carriage 315 to a position in which theconformable ligature begins to tension, a user can slide carriage 315 tothat position (or other desired position) and then rotate drive shaft310 to further tension the conformable ligature. Additionally, once thetension of the loop about the various structures in the body has beenset by fully closing the ligature capturing implant to prevent looseningof the loop, the user can simply slide carriage 315 along drive shaft310 to remove tension from the portion of the conformable ligatureattached to tensioning member 325. Additionally, if for some reason auser determines that tension must be released from the conformableligature quickly, the user can do so by sliding carriage 315 rather thanrotating drive shaft 310.

In the embodiment of FIGS. 43A and 43B, drive shaft passage 355 includesthread engaging portions 380 on the top portion of one end and thebottom portion of the other end. In other embodiments, drive shaftpassage 355 may include a thread engaging portion 380 at just one end orat any suitable point along drive shaft passage 355.

In the previous embodiments, tensioning member 325 is carried bycarriage 315 that moves along drive shaft 310 as drive shaft 310rotates. In other embodiments, the tensioning member is located at theend of a movable shaft. FIG. 44 is a diagrammatic representation ofanother embodiment of a tensioning tool. In the embodiment of FIG. 44, atensioning tool 400 can include a tool body 405, a tensioning membershaft 410 and a rotatable column 415. Tensioning member shaft 410carries a tensioning member 412 in the form of a hook. Tensioning membershaft 410 can include threads that engage with rotatable column 415.Rotation of column 415 can cause shaft 410 to actuate to move tensioningmember 412 towards or away from ligature capturing implant 420. In theembodiment of FIG. 44, a user can loop a portion of the conformableligature 418 about tensioning member 425 and rotate column 415 toactuate shaft 410 to increase or release tension in the conformableligature.

Tensioning tool 400 can include an end 425 that contacts ligaturecapturing implant 420. According to one embodiment, the end oftensioning tool 400 can act as a tool portion to tighten a rotatablering or other portion of ligature capturing implant 420 to capture theconformable ligature in ligature capturing implant 420. As one example,end 425 can be adapted to engage with tool portions 134 of the ligaturecapturing implant shown in FIG. 25.

Thus, like the embodiments of FIGS. 40-42B, the embodiment of FIG. 44includes a first portion in threaded engagement with a second portion.Rotation of the portions relative to each other causes translation oftensioning member 412. The position of tensioning member 412 can becontinuously controlled, avoiding the shortcomings of pulsed tensioning.Additionally, the tension can be easily released by rotating theportions of tensioning tool 400 in an opposite direction to movetensioning member 412 closer to ligature capturing implant 420.

In the above embodiments, a portion of the tensioning tool is rotated totranslate a tensioning member. While specific embodiments are shown,other embodiments of translating a tensioning member can be used. Forexample, the tensioning member can be coupled to the tool body. As ashaft advances due to rotation either of the shaft or another portion ofthe tensioning tool in threaded engagement with the shaft, the tool bodyand consequently, the tensioning member can be pushed away from theligature capturing implant causing tension in the ligature to increase.The tension can be reduced by rotating the portions of the tensioningtool in threaded engagement in the opposite direction relative to eachother.

According to various embodiments, a surgical procedure can be performedusing a tensioning tool that provides continuous control over tensioningthe ligature. A user can form a loop about one or more structures in apatient's body with a conformable ligature and a ligature capturingimplant. The ligature capturing implant can include ligature capturingcomprising rods, compression members or other ligature capturingimplant. The structures can include, for example, a bone, a bonefastener, a tendon, a bone graft, a plate, a rod or other structure inthe body. For example, the loop can be placed about a portion of avertebra. The user can attach a portion of the conformable ligature to atensioning member of a tensioning tool that provides a continuous rangeof control. The tensioning tool can comprise a first portion in threadedengagement with a second portion. The user can rotate the first portionrelative to the second portion to move the tensioning member to tensionthe loop. For example, a user can rotate a drive shaft to move acarriage carrying the tensioning member. In some embodiments, the usercan disengage the carriage from the drive shaft and slide the carriagealong the drive shaft to a selected position. As another example, theuser can rotate a portion of a tool engaged with a threaded shaft tocause the cause the shaft to move. The first portion can also be rotatedrelative to the second portion in an opposite direction to releasetension from the loop. The method can further comprise positioning thetensioning tool so that a connecting portion of the tensioning toolabuts the ligature capturing implant.

According to one embodiment, a spinal reduction can be performed usingtensioning tools. A method of progressive spinal reduction can compriseforming multiple loops about structures in a patient's body withmultiple conformable ligatures and ligature capturing implants andpartially tensioning each conformable ligature in turn with acorresponding tensioning tool until each conformable ligature is at adesired tension to perform spinal reduction procedure. Tensioning eachconformable ligature may comprise attaching a portion of thatconformable ligature to a tensioning member of the correspondingtensioning tool, the corresponding tensioning tool comprising a firstportion in threaded engagement with a second portion and rotating thefirst portion relative to the second portion to move the tensioningmember away from a corresponding ligature capturing implant to tensionthat conformable ligature about at least a portion of a vertebra. Thefirst portion is rotated relative to the second portion about an axisthat is substantially parallel to a primary direction of movement of thetensioning member.

Another embodiment of a method comprises providing a tensioning toolcomprising, a tool body defining a slot, a threaded drive shaft runningthrough at least a portion of the tool body, a tensioning member and acarriage coupled to the tensioning member. The carriage defines a driveshaft passage having at least one thread engaging portion to engagethreads on the drive shaft. The drive shaft passes through the driveshaft passage. The method further comprises forming a loop about one ormore structures in a patient's body with a conformable ligature and aligature capturing implant, coupling a portion of the conformableligature to the tensioning member and rotating the drive shaft to movethe carriage away from the ligature capturing implant to tension theconformable ligature. Embodiments can also include rotating the driveshaft the opposite direction to release tension from the loop. Thestructures about which the loop is formed can include, for example, abone, a bone fastener, a tendon, a bone graft, a plate, a rod or otherstructure in the body. For example, the loop can be located about atleast a portion of a vertebra for a spinal reduction procedure.

According to one embodiment, the drive shaft passage of the carriageincludes one or more additional unthreaded portions. The method canfurther comprise rotating the carriage to disengage the at least onethread engaging portion from the threaded drive shaft and sliding thecarriage along the drive shaft to a desired position.

Another embodiment of a method comprises passing a conformable ligaturearound one or more structures in a body, passing first and second endsof the conformable ligature through a loop passage in a ligaturecapturing implant to form a loop, adjusting the ligature capturingimplant to increase to resistance on the movement of the conformableligature to a selected amount that allows the conformable ligature tomove through the ligature capturing implant when a force is applied tothe conformable ligature, attaching a portion of the conformableligature to a tensioning member of a tensioning tool, rotating athreaded drive shaft of the tensioning tool to move the tensioningmember to apply tension to the conformable ligature and adjusting theligature tensioning implant to prevent the loop from loosening.According to one embodiment, rotating a threaded drive shaft of thetensioning tool to move the tensioning member comprises rotating thethreaded drive shaft to move a carriage coupled to the tensioningmember. The carriage can define a drive shaft passage having at leastone thread engaging portion to engage threads on the drive shaft andwherein the drive shaft passes through the drive shaft passage. Themethod can further comprise positioning the tensioning tool so that aconnecting portion of the tensioning tool abuts the ligature capturingimplant. According to one embodiment the drive shaft can be rotated inan opposite direction to release tension from the conformable ligature.

According to one embodiment a drive shaft passage can include one ormore additional unthreaded portions. The method can further includerotating the carriage to disengage the at least one thread engagingportion from the threaded drive shaft and sliding the carriage along thedrive shaft to a desired position.

Another embodiment comprises a tensioning tool providing continuouscontrol of conformable ligature tension, comprising a tool body defininga slot, a connection portion shaped to at least abut a ligaturecapturing implant, a threaded drive shaft running through at least aportion of the tool body, a tensioning member and a carriage coupled tothe tensioning member, the carriage defining a drive shaft passagehaving at least one thread engaging portion to engage threads on thedrive shaft and wherein the drive shaft passes through the drive shaftpassage, wherein rotation of the drive shaft causes the carriage to movetowards or away from the connection portion. According to oneembodiment, the carriage is configured to be rotated from a firstposition in which the at least one thread engaging portions are engagedwith threads on the drive shaft to a second, slidable position, in whichthe at least one thread engaging portions are not engaged with thethreads of the drive shaft. The tensioning tool can further comprise adrive shaft seat in which a first end of the drive shaft is seated, aspring that compresses between the drive shaft seat of and the toolbody, and a removable handle connected to a second end of the driveshaft distal from the first end.

The foregoing specification and accompanying figures are for the purposeof teaching those skilled in the art the manner of carrying out thedisclosure and should be regarded in an illustrative rather than arestrictive sense. As one skilled in the art can appreciate, embodimentsdisclosed herein can be modified or otherwise implemented in many wayswithout departing from the spirit and scope of the disclosure and allsuch modifications and implementations are intended to be includedwithin the scope of the disclosure as set forth in the claims below.

1. A tensioning tool for applying controlled tension to a conformableligature of a bone fixing device, comprising: a tool body having aproximal end and a distal end, the tool body defining a slot extendingalong a portion thereof; a connector at the distal end of the tool bodyconfigured to interface with a ligature capturing element of a bonefixing device attached to a spinal rod; a threaded drive shaft runningthrough at least a portion of the tool body, the threaded drive shafthaving a central rotational axis; a carriage movable along the slot viarotation of the threaded drive shaft, the carriage defining a driveshaft passage having a thread engaging portion to engage threads on thedrive shaft and wherein the drive shaft passes through the drive shaftpassage; a tensioning member coupled to the carriage, the tensioningmember configured to engage the conformable ligature of the bone fixingdevice; wherein rotation of the drive shaft such that the carriage movesaway from the connector applies a tensioning force to the conformableligature to tension the conformable ligature around a bony structure;and wherein the tensioning member is pivotable about an axis generallyperpendicular to the central rotational axis of the threaded driveshaft.
 2. The tensioning tool of claim 1, further comprising: adetachable handle connected to the drive shaft proximate the proximalend of the tool body, the detachable handle configured to permit a userto rotate the drive shaft to apply the tensioning force to theconformable ligature.
 3. The tensioning tool of claim 2, furthercomprising: a tension control device configured to determine the amountof tensioning force applied to the conformable ligature.
 4. Thetensioning tool of claim 1, wherein the connector includes first andsecond tangs configured to receive the ligature capturing elementtherebetween.
 5. The tensioning tool of claim 4, wherein the first andsecond tangs are spaced apart to permit the conformable ligature to passtherebetween.
 6. The tensioning tool of claim 5, wherein the first andsecond tangs include arcuate surfaces configured to accommodate thespinal rod.
 7. The tensioning tool of claim 1, wherein the tensioningmember includes a post extending from the carriage.
 8. The tensioningtool of claim 7, wherein the post is configured to receive a loop of theconformable ligature therearound.
 9. The tensioning tool of claim 1,wherein the tool body extends through the carriage with a portion of thecarriage including the drive shaft passage extending into the slot forreceiving the drive shaft therethrough.
 10. The tensioning tool of claim1, wherein the carriage is configured to be actuated between a firstposition and a second position; and wherein in the first position thethread engaging portion is engaged with threads on the drive shaft suchthat rotation of the drive shaft causes the carriage to move along thetool body, and in the second position the thread engaging portion is notengaged with the threads of the drive shaft such that the carriage isfreely movable along the tool body without rotation of drive shaft. 11.The tensioning tool of claim 1, wherein the carriage is pivotablebetween the first and second positions about the axis generallyperpendicular to the central rotational axis of the threaded driveshaft.
 12. The tensioning tool of claim 1, wherein the drive shaftextends from the proximal end of the tool body.
 13. The tensioning toolof claim 1, further comprising: a drive shaft seat in which a first endof the drive shaft is seated; a spring that compresses between the driveshaft seat and the tool body, wherein the first end is an end proximatethe connection portion.
 14. The tensioning tool of claim 1, wherein thetensioning member is rigidly coupled to the carriage.